The United States endoscopy market size in 1999 was $3.6 Billion.
Visualization products, which include rigid endoscopes, light sources and video accessories, represented approximately 17% of this market, in some estimations, valued at more than $600 Million. According to Stryker Corporation's 1999 Fact Book, the world endoscopy market approaches $6 Billion, and the market for visualization products continues to grow at 8-10% per year.
Of the more than 5,000 hospitals in the United States, over 80% have 4 to 6 operating rooms. The remaining hospitals have between 6 and 70 operating rooms. It may be that at least half of the estimated 30,000 operating rooms in the United States are equipped to perform endoscopic surgery. In addition to hospital operating rooms, there exist more than 14,000 medical offices with surgery suites. Again, it may be that half of these office-based surgery facilities perform endoscopic procedures. Collectively, these hospitals and surgery centers may provide more than 20,000 endoscopic operating rooms to form the 12,000 unit principal market for the invention.
A secondary market involves third-party endoscope repair organizations. Often these repair companies enter into contracts with hospitals and surgical centers to capitate repair expenses for endoscopes. Such contracts may guarantee that all the endoscopes in a facility are kept in working order. The installation of an endoscopic illumination test device at these contract facilities may enable both the hospital and the repair company to quantitatively assess the endoscopic devices before and after repair, reducing unneeded repair costs.
Endoscopes are complex optical instruments, many containing more than 30 tiny lens components. By their very nature, these devices are prone to failure from:                Overstressing during surgery (particularly orthopedic)        Carelessness during sterilization reprocessing        Poor manufacturing design or workmanship        Wear-and-tear after many sterilization cycles.        Improper repair, especially by unauthorized repair facilitiesWith costs for endoscopes ranging from $2,000 to more than $20,000, it is important to efficiently repair and keep endoscopes in use as long as possible.        
There are three products that seek to address the need for quantitative endoscope measurements. None, however, meet the market need for a cost-effective device that can be used in a clinical environment. One such product is the Lighthouse Imaging Corporation EndoBench™ tester. The advantage of the EndoBench™ tester is that it provides substantial clinically significant data to determine if an endoscope is suitable for surgery. Its cost and complexity, however, make it most suitable to a manufacturing environment.
Premise Development Corporation advertises a device called the Endotester™. Like the EndoBench™ tester, this instrument performs many important optical measurements. Unfortunately, the Endotester™ requires a custom computer system and is at least as complicated as the EndoBench™. In addition, the Endotester™ is still in breadboard form and does not perform calibrated measurements, making the device of limited value in comparing test endoscopes to reference endoscopes.
BC Group manufactures the EndoCheck.™. The EndoCheck.™., however, uses a lens to project an image of the surface of the light guide or endoscope fibers which can be used to estimate the fraction of broken fibers or it can be attached to a detector to estimate the light throughput. This system, however, cannot be calibrated to determine quantitatively the output of the light guide or endoscope. Further, the EndoCheck.™. cannot be used to measure the output of the light source, which is essential in measuring the quality of the light guides and endoscopes.
Thus, a heretofore unaddressed need exists in the industry to address the aforementioned deficiencies and inadequacies.